Parylene-Coated Elastomer Valve for Ophthalmic Dispensing
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Solution Overview
Problem
Current devices for packaging and dispensing ophthalmic solutions, particularly those containing analogs of prostaglandin, face issues with stability and sterility, as existing solutions often use preservatives that are aggressive to the eyes and fail to maintain the stability of the prostaglandin composition.
Innovation Solution
A device featuring elastomer valves coated with parylene, which allows for the sterile and clean dispensing of calibrated drops by preventing the entry of outside air while ensuring the product's stability through the use of a dispensing accessory with a first valve that allows product passage without allowing air in when relaxed, and a second valve for air filtration without product leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If antimicrobial preservative agents are added to ophthalmic solutions, then microbial contamination is prevented, but the solution becomes aggressive to the eyes
Solution Approach 1:
The invention extracts and removes the harmful preservative agents from the ophthalmic solution while maintaining microbial protection through an alternative mechanism (elastomer valve system), thereby eliminating eye aggression while preserving contamination prevention
Solution Approach 2:
The elastomer valve acts as an intermediary barrier that prevents microbial contamination without requiring chemical preservatives, thus protecting the solution while avoiding direct contact between harmful agents and the eye
2Reliability
If elastomer valves are used in dispensing devices, then sterility is maintained, but prostaglandin analogs become unstable and their concentration decreases
Solution Approach 1:
The invention changes the material parameters of the valve by coating elastomer with parylene, creating a new composite structure that maintains the elastomer's sterility function while eliminating the harmful interaction with prostaglandin analogs
Solution Approach 2:
The invention creates a composite valve structure combining elastomer (for sterility and elasticity) with parylene coating (for chemical inertness), thereby achieving both sterility maintenance and prostaglandin stability
3Ease of manufacture
If silicone elastomers are used for valves, then pharmaceutical compatibility is achieved, but product stability is compromised
Solution Approach 1:
The invention combines silicone elastomer (providing pharmaceutical compatibility and elasticity) with parylene coating (providing chemical stability), creating a composite material that maintains the benefits of silicone while eliminating product degradation
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution ensures the stability and sterility of ophthalmic solutions, particularly those containing prostaglandin analogs, by preventing microbial contamination and maintaining the composition integrity, thereby providing a reliable and effective packaging and dispensing system.
Implementation Method 1
The valve is covered with a layer of parylene... Analyses have shown strong interaction between the analogs of prostaglandin and the components of dispensing devices... strong interaction affected valves made of silicone elastomer... Parylene processing resolves this problem posed by the silicone or fluorosilicone membranes
Implementation Method 2
The dispensing accessory comprises a first valve made of elastomer material allowing the product to pass through when the dispensing accessory is stressed without allowing outside air to move in the reverse direction when the dispensing accessory is relaxed
Data Source
AI summary
Device for packaging and dispensing drops of a substance for ophthalmic use, generally fluid, semi-fluid or in suspension, emulsion or oily solution including a dispensing accessory with a first valve made of an elastomer material that allows the substance to pass through when the dispensing accessory is stressed, without allowing outside air to pass through in the opposite direction when the dispensing accessory is relaxed, characterized in that the first valve is covered by a layer of Parylene.